Z-0196-2019Class II

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip...

Name: Z-0196-2019 Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip...
Creator: Medacta Usa Inc
Published: 2017-11-15
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2017-11-15 / Terminated / root cause: packaging

FDA source

Medacta Usa Inc began a recall of Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery on 2017-11-15. FDA classified it as Class II and gives the reason as "Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0196-2019
Classification: Class II
Status: Terminated
Initiated: 2017-11-15
Posted: 2018-10-19
Terminated: 2019-03-29
Recalling firm: Medacta USA, Inc.
Product: Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.
Quantity in commerce: 837 units
Distribution: NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
Product codes and lots: a) REF 01.13.100L, GTIN 07630030803130 b) REF 01.13.101L, GTIN 07630030803154 c) REF 01.13.102L, GTIN 07630030803178 d) REF 01.13.103L, GTIN 07630030803192 e) REF 01.13.104L, GTIN 07630030803215 f) REF 01.13.105L, GTIN 07630030803239 g) REF 01.13.106L, GTIN 07630030803253 h) REF 01.13.107L, GTIN 07630030803277 I) REF 01.13.108L, GTIN 07630030803291 j) REF 01.13.100R, GTIN 07630030803147 k) REF 01.13.101R, GTIN 07630030803161 l) REF 01.13.102R, GTIN 07630030803185 m) REF 01.13.103R, GTIN 07630030803208 n) REF 01.13.104R, GTIN 07630030803222 o) REF 01.13.105R, GTIN 07630030803246 p) REF 01.13.106R, GTIN 07630030803260 q) REF 01.13.107R, GTIN 07630030803284 r) REF 01.13.108R, GTIN 07630030803307 Lots produced with the old version of the packaging, including lot numbers less than 169041.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0196-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0196-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-19

Product code LZO

K170845Class IIMiniMAXMedacta International S.A. / cleared 2017-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)